NobelZygoma 45°
K-Number: K152093 · 2016-03-16
ApplicantNobel Biocare AB
Decision Date2016-03-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
NobelZygoma 45° is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2016-03-16 under approval number K152093. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NobelZygoma 45°?
NobelZygoma 45° is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by Nobel Biocare AB. The 510(k) number is K152093.
When was NobelZygoma 45° approved by the FDA?
NobelZygoma 45° received FDA 510(k) clearance on 2016-03-16, under approval number K152093.
What company makes NobelZygoma 45°?
NobelZygoma 45° is manufactured by Nobel Biocare AB.
What is the FDA product code for NobelZygoma 45°?
The FDA product code for NobelZygoma 45° is DZE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.